IVAX Receives Final Approval on Cilostazol Tablets 100 mg.MIAMI -- IVAX Corporation (AMEX AMEX See: American Stock Exchange :IVX) (LSE LSE - Language Sensitive Editor :IVX.L) (WSE:IVX) has received a final approval from the U.S. Drug and Food Administration (FDA) for its Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar (ANDA) for cilostazol tablets, 100 mg. This product will be sold through the company's wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. , IVAX Pharmaceuticals, Inc. Cilostazol tablets, 100 mg is the generic equivalent of Pletal(R) Tablets, which is marketed by Otsuka American Pharmaceutical, Inc. for intermittent claudication Intermittent Claudication Definition Intermittent claudicationis a pain in the leg that a person experiences when walking or exercising. The pain is intermittent and goes away when the person rests. (pain in the legs that happens when walking and goes away with rest). According to IMS data, U.S. sales of cilostazol tablets, 100 mg were $154.2 million for 2004. IVAX Corporation, headquartered in Miami, Florida, discovers, develops, manufactures, and markets branded and brand equivalent (generic) pharmaceuticals and veterinary products in the U.S. and internationally. Copies of this and other news releases may be obtained free of charge from IVAX' website at http://www.ivax.com. Except for the historical matters contained herein, statements in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Investors are cautioned that forward-looking statements, including the statements regarding IVAX' generic portfolio, involve risks and uncertainties which may affect the company's business and prospects, including the risks that the launch of cilostazol tablets in 100 mg strength may be delayed; changing market conditions; the availability and cost of raw materials and other third party products; the impact of competitive products and pricing; and other risks and uncertainties based on economic, competitive, governmental, technological and other factors discussed in the Company's Annual Report on Form 10-K and its other filings with the Securities and Exchange Commission. Pletal(R) is a registered trademark of Otsuka Pharmaceutical Company, Ltd. |
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